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Friday, March 6, 2015

March 2015 HITECH Interoperababble Update

Five Republican senators -- John Thune, Lamar Alexander, Pat Roberts, Richard Burr, and Mike Enzi -- have just aired their dismay with the progress and status of the HITECH/Meaningful Use program, over at The Health Affairs blog. Given that it's not firewalled (unlike nearly all of their content), and given that it constitutes a public record, I reproduce it below for your convenience.

Two years after releasing the white paper, and six years since enactment of the HITECH Act,
the question remains. There is inconclusive evidence that the program
has achieved its goals of increasing efficiency, reducing costs, and
improving the quality of care.

We have been candid about the key reason for the lackluster
performance of this stimulus program: the lack of progress toward
interoperability. Countless electronic health record vendors, hospital
leaders, physicians, researchers, and thought leaders have told us time
and again that interoperability is necessary to achieve the promise of a
more efficient health system for patients, providers, and taxpayers.

We were pleased that the Office of the National Coordinator for
Health Information Technology (ONC) recognizes the concern of hospitals,
providers, patients, and other stakeholders, and recently released a
draft roadmap for interoperability. In it, ONC proposes to work with stakeholders to develop minimal standards for the safe and
secure exchange of EHRs. We appreciate ONC’s efforts to identify the
steps necessary to achieve true interoperability of EHRs, but we are
concerned that the draft speaks in generalities and does not address all
of the concerns raised about interoperability in the REBOOT report.

The ONC roadmap provides a framework for responsibility, governance,
and accountability in regard to the future development and
implementation of interoperable EHRs. But instead of offering specific
objectives, deadlines, and action items, ONC’s roadmap falls short on
the nitty gritty technology specifics that vendors and providers need
when developing IT products. We are left with many outstanding questions
about how to achieve interoperability and how to address the cost,
oversight, privacy, and sustainability of the meaningful use program.

Interoperability

A truly interoperable health system in local communities and across
the country will enable physicians, hospitals, and other health care
providers to seamlessly share patient information, such as medical
histories or diagnostic tests, through a secure network. Sharing this
information should improve care and reduce costs by allowing physicians
to better coordinate care. For example, health information exchange
between providers should prevent duplicative tests and harmful drug
interactions.

After spending $28 billion so far of the $35 billion total taxpayer investment, significant
progress toward interoperability has been elusive. Stage 1 of the
meaningful use program failed to include any meaningful health
information exchange requirements, and lacked a vision to achieve
interoperability. Instead, Stage 1 incentivized the widespread adoption
of EHR systems that providers now say are difficult to use and lack the
ability to exchange information without costly upgrades.

We are now well into Stage 2 of the Meaningful Use program and
providers are struggling to meet even modest health information exchange
requirements. According to a report released by the Centers for Medicare and Medicaid Services (CMS) on
February 10, 2015, only 131,905 out of more than 500,000—or roughly 25
percent—of eligible medical providers and hospitals had attested to
either Stage 1 or Stage 2 for 2014. Responding to stakeholder feedback,
CMS allowed more flexibility to providers to meet Stage 2 requirements.

By remaining in listening mode, ONC proposed high-level goals for how
to achieve interoperability, like building on existing infrastructure
and empowering individuals, but the roadmap fails to outline real and
actionable next steps. It is not enough for ONC to identify factors it
believes are important. It must also delineate how it will find specific
solutions to these concerns. The HITECH Act was clear: ONC is supposed
to certify EHRs that can meet the program requirements for the
meaningful use of EHRs.

Meaningful use of EHRs is supposed to deliver value to patients and physicians, but instead we have reports that have shown that
ONC certified products fail to deliver the value of easily exchangeable
health information to better coordinate care. They are also incredibly
expensive with no guarantee that providers purchasing certified products
will achieve the Meaningful Use program requirements.

Indeed, through the ONC certification program, ONC has had the
ability to achieve interoperability, but instead ONC is still
struggling. Nothing makes this point more clear than this fact: Stage 2
meaningful use was promised to be the stage when health providers were
interoperable yet we are well into Stage 2 and ONC is just now releasing
its vision for interoperability with a high level roadmap.

We have seen many high-level documents on interoperability: the JASON
reports, the Health IT Policy and Standards Committees’ reports, the
Connecting Health and Care for the Nation: A 10-Year Vision to Achieve
an Interoperable Health IT Infrastructure report, and the Federal Health
IT Strategic Plan 2015-2020 report. All of these reports, as well as
the ONC’s latest roadmap, are missing the same thing: practical and
actionable steps to ensure a proper return on the American people’s
investment.

Increasing Costs

In 2009, the Congressional Budget Office (CBO) estimated
that fully integrated interoperability would save the Medicaid and
Medicare programs $12.5 billion through 2019. These savings have yet to
materialize and with 50 percent of doctors unable to meet current
program requirements, it is unlikely that taxpayers will see these savings in
the near future. Moreover, the number one complaint we hear from
providers is the unexpected costs of maintaining and upgrading their
systems.

ONC does not describe how it will determine the costs associated with
the adoption of expanding interoperable platforms. Nor does ONC explain
how it would evaluate cost or incorporate cost control into the
development and scaling of interoperability. Provider concerns about the
cost of complying with the program should be addressed in the roadmap.

We appreciate the notion that
as new models of care begin to reward providers for outcomes, changing
incentives will reward interoperability. We agree. However, we live in
the aftermath of the HITECH Act, where to date $28 billion have not
resulted in significant improvements to clinical care coordination or
quality. Without concrete immediate and long-term steps, tied into
accurate, usable (and collectable) performance measures, we will
continue to see a meager return on investment.

Lack of Oversight

One way to improve oversight of the program is to put in place
measures to gauge success. ONC appears to be taking a step in the right
direction by describing seven different lenses to measure and evaluate
the quantity and quality of information flow within interoperable
systems, such as who is exchanging information, and where and what type
of information is being exchanged. However, without specific performance
goals for each type of measurement, it is unclear how ONC will measure
success. In addition to defining these metrics, effective oversight
includes describing how the metrics will be collected, analyzed,
reported, and used for decision making.

The fiscal year 2015 Omnibus Appropriations Act required ONC to issue
a report on information blocking — the practice that EHR vendors, and
sometimes hospitals and physicians, use to prevent electronic
information exchange as a way to gain a competitive advantage in the
health care marketplace. The report will give Congress a better
understanding of the extent to which information blocking happens and a
comprehensive strategy on how to address it. It will also provide a good
example of how ONC exercises its oversight responsibility.

Patient Privacy at Risk

The security of patients’ personal health information in EHR systems
is a real and immediate concern to us. According to a warning the
Federal Bureau of Investigation (FBI) issued to health care providers in
April 2014, the health care industry has the highest volume of cyber
threats and the slowest response time. The industry “is not as resilient
to cyber intrusions compared to the financial and retail sectors,
therefore the possibility of increased cyber intrusions is likely,” the FBI stated.
Unlike a credit card number, the information contained in a patient’s
health record is impossible to reissue. Health records contain financial
records, personal information, medical history, and family
contacts — enough information to steal and build a full identity or use
for valuable research purposes.

The ONC roadmap describes collaboration across several government
agencies to accomplish their security goals. It says the Department of
Health and Human Services will work with the Office of Civil Rights and
industry to develop and propose a uniform approach to developing and
enforcing cybersecurity in health care in concert with enforcement of
HIPAA Rules.

However, the roadmap lacks clear, obtainable goals regarding security
requirements and implementation. Additionally, the costs for our future
security infrastructure are unknown, as well as who will pay for it. As
new cyber threats emerge every day, this administration must answer
these questions quickly. The recent hack on a major health insurer that
compromised personal information, including Social Security numbers and
health histories, of tens of millions of Americans highlights the urgent
need for an appropriate framework to protect patient privacy.

Program Sustainability

The long-term sustainability of EHR systems remains one of the
biggest unknowns. ONC’s roadmap is surprisingly silent on this topic,
which is stunning considering that there is only $7 billion in funding
left from the HITECH Act. While the President’s Budget does request a
significant increase in funding for ONC, the administration seems to
ignore the reality that taxpayers have already committed billions of
dollars toward a goal that is still vague.

According to ONC, implementing EHR systems range from $15,000 to $70,000 per provider. According to a September 2014 IBIS World Report on
EHRs, nearly 45 percent of physicians from the national survey reported
spending more than $100,000 on a system. About 77 percent of the
largest practices spent nearly $200,000 on their systems. However, even
these estimates fail to consider upgrade and vendor costs associated
with running these systems. Numerous stakeholders have stated that one
large obstacle to interoperability and sustainability is the cost of sharing data among different vendors.

ONC envisioned the State Health Information Exchange Program would help facilitate
this exchange, and taxpayers spent over $500 million on this effort.
Yet, the program has failed to provide a long-term approach to
information exchange. According to a RAND Studypublished in December 2014, only about 25 percent of the nation’s
health information exchanges are considered financially stable by those
who run them. These programs’ inability to sustain operations without
federal funding triggers more questions. With HITECH Act funding
dwindling, we fear that time is running out for ONC to make meaningful
advancements toward interoperability.

Looking Ahead

In listening to the concerns from EHR vendors and EHR users from
across the care continuum, ONC has taken an important turn under the
leadership of Dr. Karen DeSalvo. The previous ONC leadership did not
understand the difficulty and enormity of creating government-approved
products in a market that struggled to exist before government
incentives arrived.

As a result, our nation’s health care providers are stuck with the
huge cost of unwieldy systems trying to conform to government mandates.
They are stuck adopting EHR systems which don’t fit into their
established workflows. And if they actually want to share their
patients’ data, they are stuck with even more costs imposed by vendors.

At the center of all this is the patient who must sit quietly in the
exam room looking at her physician use a computer instead of directly
talking with her, who likely has seen no better access to her own data,
and who is struggling to understand why her doctor has such a difficult
time getting her lab results.

That the ONC roadmap recognizes these concerns is a welcome change.
High-level ideas are important, but we are concerned that without
specific requirements and action items, we will not advance towards the
goal of improving health care coordination and patient care, which was
the intent of the HITECH Act.

Fair enough. This is one instance in which I would support congressional hearings (preening Grandee warts and all), with ONC and CMS officials called to testify. Not that I buy all of the foregoing uncritically. For one thing, I have noted before what I call "Health IT Policy ADHD." Major legislation gets passed and funded, and when we don't get immediate, dazzling results, we go sour on it, lamenting its "failure," and calling for its demise. HITECH is not that old. There have really only been four years of full-bore boots-on-the-ground operation. REC contracts were let in 2010, and the RECs spent most of their first year getting their sea legs under them and scurrying about hustling skeptical clinical participants.

"Two years after releasing the white paper, and six years since enactment of the HITECH Act,
the question remains. There is inconclusive evidence that the program
has achieved its goals of increasing efficiency, reducing costs, and
improving the quality of care."

Again, the Meaningful Use program has only been in operation since 2010. "Inconclusive evidence" is all you're going to get with respect to most core aspects of the program at this point.

We never tire of citing the "information superhighway" analogy. Fine. The U.S. Interstate Highway system took more than 35 years to complete. Significantly and sustainably transforming the incredibly complex, heterogeneous U.S. healthcare delivery and information infrastructure easily rivals it in scale and exceeds it in complexity by orders of magnitude. Moreover, this $35 billion outlay comes to about $22 per capita per year since the deployment of the HITECH program five years ago. The latest NHE per capita expenditure is about $10k. $22 is about 0.2% of that (0.0022). Close to being a rounding error.

"We have been candid about the key reason for the lackluster
performance of this stimulus program: the lack of progress toward
interoperability."

My views on what I coined as "Interoperababble" are well-known. I remain skeptical that HL7® FHIR® will provide the seamless data exchange salvation proffered by its evangelists. Whether it ever rises to meet the IEEE definition of "interoperability," well, I seriously doubt it.

Interoperability: Ability of a system or a product to work with other systems or products without special effort on the part of the customer. Interoperability is made possible by the implementation of standards.

"Standards." Yeah. In fairness, I have to recognize that my call for at least studying a Data Dictionary Standard will be rather uniformly ignored in Wonkistan -- that horse having probably long left the barn.

"Without special effort on the part of the customer." What will probably happen is that we'll define "special effort" down, so that increased complexity of workflow and additional interop recipient data repository architectural burdens come to be seen as the norm.

When it comes to creating electronic systems that support clinical
care, the dominant paradigm has been the electronic health record. The
reason for this is obvious; for decades the paper record has had a
central role in care delivery. However, as care delivery comes to
embrace care coordination, patient engagement and shared
decision-making, it is becoming obvious to all that a patient repository
of information is but one of the components that are needed to support
these facets of clinical care.

As always, building systems to support any activity requires input
from those doing the work. Because my background is general internal
medicine and primary care, systems that support primary care are of
particular interest. We all know that patient care requires access to
up-to-date patient information – the domain of the EHR, but what about
the clinical work activities that require collaborative use of patient
information? How are these activities best supported electronically?
Fortunately, clinicians are becoming more vocal about their work support
needs.

In Electronic health record functionality needed to better support
primary care Krist, et al. provide a list of functions that could
support care coordination better than current systems...

These functions help to manage care processes that are focused around
interactions between various types of clinicians across different care
settings. They show the extent to which communication of decisions,
intentions, and outcomes are a central component of primary care.
Supporting these functions in software requires tools to manage and
track messages, create and manage virtual teams, locate and allocate
resources, and other functions beyond accessing patient information.
The electronic health record is necessary for this functionality, but
alone is not sufficient to provide it...

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About Me

Cheryl D. Prince, CQA, CMQ/OE

Corporate Director of Quality, Gilbane Building Company, Concord, CA. My wife and best friend of more than four decades. Scary smart. The kindest person I ever met.

DISCLAIMER:

I write this blog wholly on my own time and my own dime. The views proffered are expressly my own as a concerned and active citizen/taxpayer (in addition to being the result of my substantive experience in the various IT fields), and in no way reflect any policy views of my former employer, notwithstanding that some of the thinking has indeed obviously been spurred by the implications of the work with which I have been doing for them.

FAIR USE POLICYI cite a ton of news and web sources spanning the breadth of relevant technical and policy domains, sometimes at substantial length. I believe I remain well within the bounds of "Fair Use," as [1] I am not doing any of this for profit, [2] I always provide attribution and links -- which, [3] far from negatively impacting any copyright holders' commercial interests, might actually increase traffic to and interest in their offerings.

Nonetheless, should I post anything of yours regarding which you have any objection, just let me know and I will remove it forthwith.